Nutraceutical approach to moderate cardiometabolic risk: Results of a randomized, double-blind and crossover study with Armolipid Plus

►Nutraceutical treatment reduces total cholesterol (−13%).►Nutraceutical treatment reduces low-density lipoprotein (LDL)-cholesterol (−21%) and increases high-density lipoprotein-cholesterol (4.8%).►Nutraceutical effectiveness on total and LDL-cholesterol reduction is similar to pravastatin.►Nutraceutical treatment is useful and safe in subjects with moderate cardiovascular risk.

BackgroundPrimary cardiovascular prevention may be achieved by lifestyle/nutrition improvements and specific drugs, although a relevant role is now emerging for specific functional foods and nutraceuticals.ObjectivesThe aim of this study was to evaluate the usefulness of a nutraceutical multitarget approach in subjects with moderate cardiovascular risk and to compare it with pravastatin treatment.SubjectsThirty patients with moderate dyslipidemia and metabolic syndrome (according to the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults) were included in an 8-week randomized, double-blind crossover study and took either placebo or a nutraceutical combination that contained red yeast rice extract, berberine, policosanol, astaxanthin, coenzyme Q10, and folic acid (Armolipid Plus). Subsequently, they were subjected to another 8-week treatment with pravastatin 10 mg/d. This dosage was selected on the basis of its expected −20% efficacy in reducing low-density lipoprotein-cholesterol.ResultsTreatment with Armolipid Plus led to a significant reduction of total cholesterol (−12.8%) and low-density lipoprotein-cholesterol (−21.1%), similar to pravastatin (−16% and −22.6%, respectively), and an increase of high-density lipoprotein-cholesterol (4.8%). Armolipid Plus improved the leptin-to-adiponectin ratio, whereas adiponectin levels were unchanged.ConclusionsThese results indicate that this nutraceutical approach shows a lipid-lowering activity comparable to pravastatin treatment. Hence, it may be a safe and useful option, especially in conditions of moderate cardiovascular risk, in which a pharmacologic intervention may not be appropriate.